By Neil E. Levin, Certified Clinical Nutritionist
The May 2004 issue of Consumer Reports contains an article sharply
critical of dietary supplements, called "Dangerous Supplements-Still At Large".
Unfortunately for consumers, Consumer Reports has once again failed to
deliver fair and accurate facts when reporting on natural products. I
believe that a bias is present in the experts selected by the magazine
as their trusted sources for these types of stories. In some cases the
supplements' safety record as found in peer-reviewed, published science
is far from what I am reading in the magazine's report. Not that Consumer
Reports is alone in this medical/media bias against supplements.
It is clear that many medical and regulatory officials do not understand
orrespect dietary supplements. They do not believe that they are regulated
properly, even when the FDA claims otherwise. And nothing should be
allowed to interfere with the ever-expanding drugging of America.
Where there is a conflict between a food and a drug, or an herb and a
drug, the doctors assume that the drug is automatically blameless and
necessary; but the supplement or food needs to be restricted, labeled or banned for
daring to interfere with their medical treatments.
If another country bans a supplement, that is presented as evidence of
its harm, and that ban used to criticize our government for not cracking
down on supplements here. Of course, that argument does not apply to foreign
refusal to accept our exports of genetically modified food due to an absence of
safety data. In that case their refusal to carry what we have approved
in the USA is not respected. Experts use the foreign ban argument both
ways, even though it is obviously contradictory. Which proves that the
argument is phony. Why should new types of food be automatically exempt from most
safety regulations while dietary supplements (the category of food with the
fewest safety problems on record) can get banned over media hysteria, despite
having almost no hard evidence against them?
In the case of the herb ephedra, the mainstream dietary supplement
manufacturers had begged the FDA to institute mandatory label and dose
restrictions for many months before the ban was announced, promising to
support the changes. But there was no 'smoking gun' proving serious harm
that could provoke FDA action.
Ephedra was finally banned, the ban prompted by the novel new theory
that because supplements' safety is assumed rather than proven, that the
government needs only a reasonable suspicion of human harm to take
action, rather than actual evidence of human harm:
"...historical use is not always enough by itself to prove the safety of
a supplement even if it has been consumed for centuries or used in folk
medicine..."
Only the gigantic amount of pressure in the media from misguided
consumer advocates led the government to overrule the FDA and institute a ban
based on fear.
More regulation is proposed to institute controls over dietary
supplements that are stricter even than the requirements for over-the-counter drugs.
But OTC drugs kill many thousands of people a year. Dietary supplements are
accused by their foes of killing maybe 150 a year, but the actual death
statistics list only a handful of probable deaths: typically zero from
vitamins, a few from iron supplements, and maybe 5 a year from all plant
poisonings. Why - other than ignorance and fear - would anyone recommend
to regulate and maybe ban supplements based on purely theoretical dangers,
when the same kind of evidence would be legally inadmissible against OTC
drugs that are already proven to be thousands of times more deadly, despite
having gone through the required safety testing?
The "adverse reports" that the FDA received about ephedra would not be
allowed to be used as evidence of harm for any drug. Yet they are
'Exhibit A' against ephedra. The Rand Corp. review of studies on ephedra noted
the anecdotal reports, but also noted that they were not valid evidence and
that they were contradicted by the over 50 well-designed studies that were
also reviewed. In all of those studies, there was a total of zero cases of
deaths, strokes, or heart attacks in any of the people using ephedra.
This has been confirmed by science at Harvard and by the Hemmorrhagic Stroke
Study, neither of which reported any serious adverse effects from
ephedra.
Yet politicians and medical experts repeatedly cite the unproven reports
as evidence of danger, while ignoring the century-long trail of legitimate
science proving otherwise. And Rand reported safe, steady weight loss in
these ephedra studies.
Ephedra was combined with caffeine and other substances in products that
do cause temporary, reversible side effects for some people. Yet caffeine
is rarely blamed for these side effects, and it is proposed to exclude
caffeine from this new regulation of stimulants, even though caffeine is a very
strong blood vessel constrictor which can cause increased blood pressure
and headaches.
Another herb is slammed in the article for being too similar to ephedra.
It is bitter orange (citrus aurantium), which actually does NOT have a
similar action to ephedra, contrary to what the article states. It does not have
the same central nervous system effects and does not tend to constrict blood
vessels and raise blood pressure, in contrast to what Consumer Reports
claims. Bitter orange has totally different alkaloids than ephedra, with
different effects. In one study bitter orange also helped regulate
irregular heartbeat, contradicting the article once again. But the attack machine
will keep fighting this herb until the insurance companies withdraw support,
and the prices will rise as it becomes uninsurable. Which is what is already
happening to kava.
The Polynesian herb kava kava is accused in the article of probably
causing liver disease. There is virtually no proof of this. A noted toxicologist
looked at the evidence and pronounced it to be only a few unrelated
cases, with no real link between the liver damage and kava use. Meanwhile
acetaminophen (Tylenol and other brands) is blamed for thousands of
deaths a year, and is the number one cause of liver failure noted by hospitals
(in England so many people were dying of this drug that it was forced into
being sold only as blister packs in small-count boxes). But kava suppliers are
finding it harder and harder to get liability insurance, because of the
media scares. Some countries have already banned kava, despite an almost
total lack of evidence that it causes even as much harm as a cup of
coffee. Again, a foreign ban is proof of harm - unless they ban something we
export, in which case it's an unfair trade practice.
The supplement andro (androstene) is also being accused of bad side
effects.Certain sports groups have banned it as a performance enhancer, which is
cited as evidence of it's being harmful. (Huh?)
The bottom line is that, by design or by ignorance, dietary supplements
are being persecuted despite their lack of any real deadly potential.
Medical and pharmaceutical interests are pushing politicians and consumer groups
to clamp down on products that are safer than the food we eat. Food
allergies kill hundreds of people a year; food poisoning thousands. Less than a
handful of deaths are really scientifically and medically linked to
supplements, and they are so far below the statistical measurement
standards as to be virtually zero. Even the FDA has admitted as much: that the
deaths blamed on ephedra were so few as to be below their ability to
distinguish from other random, unexplained causes of death in any large population.
And finally, Consumer Reports tells us to avoid taking more than the
so-called Safe Upper Limits for vitamins. These SULs are not a gold
standard, being sometimes arbitrarily set even in the absence of any
medical records proving that higher levels have harmed anyone. With no problems
on record from taking a vitamin, the NAS still allowed SULs to be set by
adding 20% to the estimated daily average intake; with no proof that our intake
was adequate or overabundant.
This is regulation for regulation's sake! This is medical bias against
dietary supplements! I, for one, am sick not from my daily supplements,
but from the unbelievable gall of those who think that I will believe them
when they tell me that safe things are dangerous, that they can set limits on
my diet based solely on their unproven theories, and that the government is
always my unbiased friend and protector.
I welcome reasonable government regulation based on science, not on this
load of bullfeathers that is intended to scare us into compliance. The
FDA has repeatedly said that it has the tools to regulate supplements and
protect the public. Why don't the politicians believe them?
The opinions given are solely those of:
Neil E. Levin
Certified Clinical Nutritionist
(630) 942-8094 extension 215, FAX: 942-8170
Product Consultant and Truth Advocate for Now Foods
President: Nutrition for Optimal Health Association, Inc.
Member: Clinical Nutrition Certification Board, Scientific Council
Top of Document